Incidence and Risk Factors for Trocar Site Incisional Hernia Detected by Clinical and Ultrasonographic Examination.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- clinical TSIH incidence
研究概览
简要总结
Trocar site incisional hernia (TSIH) is the most frequent complication associated to laparoscopic surgery. Few studies currently describes its real prevalence or risk factors. The aim of this study is to determine the real incidence of TSIH and to identify risk factors in the investigator's series of patients.
A cross sectional, prospective study is performed including consecutive patients who underwent a laparoscopic procedure during a four months period. All the patients are assessed both clinically (TSIHc) and by an ultrasonographic exam (TSIHu). Main variable studied is the incidence of TSIH. A multivariate analysis is performed to identify risk factors.
详细描述
Single-centre cross-sectional study based on prospective clinical and radiological assessment and retrospective risk factor analyses performed at a single hospital.
All consecutive patients who underwent laparoscopic surgery (cholecystectomy, colon resection, adrenalectomy, Nissen fundoplication and appendectomy) during a four months period were included in the study. At least 30 months after hospital discharge, they were invited by telephone to participate in the study. Detailed project information was provided, and those who accepted received an appointment for an outpatient visit and a dynamic ultrasound. Informed consent was obtained from all participants. In all patients, the umbilical trocar wound was closed with an interrupted suture with synthetic braided absorbable 2/0 suture (Novosyn® or Safil®). During the postoperative outpatient visit, clinical and ultrasonographic examinations were performed. To increase study homogeneity, all clinical examinations and ultrasounds were performed by a single surgeon and a single radiology resident supervised by the same abdominal radiology consultant, respectively. Sonography was performed with an Applio 500 equipment (Toshiba, Japan) with a 3.5MHz convex probe and a 7MHz linear probe. The ultrasound diagnosis was based on the identification of an abdominal wall defect with intraabdominal tissue protrusion. The main variables of the study were clinical (TSIHc) and ultrasound (TSIHu) diagnosis of incisional hernia. All results and variables were introduced in a previous specifically designed database (File MakerPro 11.0v3 © 1984-2011 FileMaker, Inc.). Data were collected from clinical interviews, physical and radiological examinations and the electronic medical record. Statistical analyses were performed using the SPSS statistical software (IBM SPSS® Statistics).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previous laparoscopic surgery
- •Age ≥18 years
- •Informed consent signed
排除标准
- •Previous umbilical hernia repair
- •Age < 18 years
- •Informed consent not signed
- •Failure to attend the postoperative appointment
结局指标
主要结局
clinical TSIH incidence
时间窗: 30 seconds
Presence / absence palpableTSIH (yes / not)
ultrasonographic TSIH incidence
时间窗: 1 minute 30 seconds
Identification of an abdominal wall defect with intraabdominal tissue protrusion (yes /not) Caudal and cranial diameters of the abdominal wall's defect (cm)
次要结局
- Risk factors for TSIH(5 minutes)
研究者
Ana Ciscar
General and digestive surgery specialist
Hospital de Mataró
